- Antiretroviral therapy has increased the lifespan of people with human immunodeficiency virus (HIV), but recent research suggests that people with HIV also have an increased risk of developing cardiovascular disease. To better understand the prevalence and effects of heart disease in people with HIV, researchers are interested in comparing heart imaging and metabolism studies to see if there are differences between HIV-positive and HIV-negative people.

Objectives:

- To study metabolism and heart function in people with HIV compared with healthy HIV-negative volunteers.

Eligibility:

- Individuals at least 18 years of age who either have been diagnosed with HIV or are healthy HIV-negative volunteers.

Design:

Participants will be evaluated with a physical exam, detailed medical history, and routine blood and urine tests including HIV testing.

Participants will have the following imaging scans:

Cardiac magnetic resonance imaging (MRI) to study the health of the heart and blood vessels

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

Intramyocardial triglyceride

Enrollment:

168

Study Start Date:

March 2010

Estimated Study Completion Date:

August 2015

Detailed Description:

HIV is now a chronic infection as patients with access to antiretroviral therapy have significantly improved life expectancies. Patients with HIV also have an increased risk of cardiovascular disease. Thus, cardiovascular disease is an important potential co-morbidity for patients living with HIV. The current proposal will perform a detailed cardiovascular assessment using state-of-the-art imaging techniques to evaluate intramyocardial lipid as well as coronary artery disease and myocardial function in a cohort of 100 HIV infected patients and 30 healthy volunteers as controls. This is an early exploratory cross-sectional study designed to both assess the burden of disease and apply novel techniques in this unique population.

Eligibility

Ages Eligible for Study:

18 Years to 99 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

HIV-Infected Participants Criteria:

INCLUSION CRITERIA:

Age 18 years or greater

Documented HIV infection

Willingness to have stored samples

EXCLUSION CRITERIA:

Subject is deemed unable to comply with requirements of study participation.

Subjects with contraindication to MRI scanning. These contraindications include but are not limited to the following devices or conditions:

Implanted cardiac pacemaker or defibrillator

Cochlear implants

Ocular foreign body (e.g. metal shavings)

Embedded shrapnel fragments

Central nervous system aneurysm clips

Implanted neural stimulator

Medical infusion pumps

Any implanted device that is incompatible with MRI.

Subjects requiring sedation for MRI studies.

Subjects with a condition precluding entry into scanner and acquisition of scans (e.g. morbid obesity, claustrophobia, back pain, motion disorders).

Women who are lactating, pregnant, or actively seeking to become pregnant.

History of severe allergic reaction to gadolinium contrast agents despite the use of premedication with an anti-histaminic and cortisone.

Estimated glomerular filtration rate (eGFR) <60 cc/min/1.73m(2).

Creatinine value >3.0 mg/dl

For Coronary CTA with Iodine-Based Contrast*:

Contraindication to the use of CT contrast agents:

Creatinine value >1.4 mg/dl or eGFR <60 cc/min/1.73m(2).

History of multiple myeloma

Use of metformin-containing products less than 24 hrs prior to contrast administration

History of significant allergic reaction to CT contrast agents

Subjects with contraindication precluding the use of beta blockers necessary to perform the coronary CTA. These include:

Clinically significant asthma

Active bronchospasm

Moderate or severe chronic obstructive pulmonary disease (COPD)

2nd or 3rd degree AV block

Decompensated cardiac failure

Allergy to beta blockers

Systolic blood pressure <100 mm Hg

Guidelines for use of beta blocker is outlined in Appendix 1.

Participants who are eligible for MRI but who are not eligible for cardiac CT scan will be allowed to participate in the non-CT portion of the study.

Healthy Control Criteria:

INCLUSION CRITERIA:

Age 18 years or greater

Willingness to have stored samples

EXCLUSION CRITERIA:

All of the exclusion criteria for HIV-infected participants listed above apply to healthy controls. In addition, the following exclusion criteria will also be applied to healthy controls:

Clinically significant, systemic illness (serious infections or significant cardiac, pulmonary, hepatic, or other organ dysfunction) which in the judgment of the investigators would compromise the patient s ability to tolerate this study.

History of or current known cardiovascular disease.

HIV infection.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089114